Ignite Creation Date:
2024-05-05 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00611130
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2008-01-28
Brief Title:
Vigabatrin for Treatment of Cocaine Dependence
Sponsor:
Catalyst Pharmaceuticals Inc
Organization:
Catalyst Pharmaceuticals Inc
Study Overview
Official Title:
Vigabatrin for Treatment of Cocaine Dependence A Phase II Study
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment
Detailed Description:
Cocaine addiction a serious public health concern associated with significant medical social and economic consequences is difficult to treat using traditional psychosocial and behavioral therapies Despite testing of a number of different agents for cocaine dependency there remains no proven pharmacologic treatment for cocaine addiction
The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system CNS Cocaine administration increases the levels of dopamine a neurotransmitter associated with sensations of pleasure and reward Therefore blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction
Another neurotransmitter gamma-aminobutyric acid GABA suppresses striatal dopamine release and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward Thus drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction
The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system CNS Cocaine administration increases the levels of dopamine a neurotransmitter associated with sensations of pleasure and reward Therefore blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction
Another neurotransmitter gamma-aminobutyric acid GABA suppresses striatal dopamine release and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward Thus drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None